PRNewswire - Monday September 28, 1998

Of 39 patients who completed 16 weeks of treatment with Ziagen+Combivir, 28 (72 percent) had undetectable virus (less than 400 copies/mL; Roche Amplicor Assay), with 21 of those having less than 50 copies/mL (Roche Ultrasensitive Assay). These patients had previously been treated only with monotherapy or combinations of nucleoside analogue drugs and in a few cases with nonnucleoside reverse transcriptase inhibitors.

"The results of this study, while preliminary, are significant in that they demonstrate the potential utility of Ziagen+Combivir in patients who have already been heavily treated with other nucleoside analogues," said Neil Graham, M.D., director, HIV, U.S. Medical Affairs at Glaxo Wellcome. "It is important to understand better the treatment of patients who are already showing less than complete viral suppression with other nucleosides."

Subjects enrolled in the study had received a minimum of eight weeks of previous treatment with one or more nucleoside analogues, and less than one week of treatment with any protease inhibitor. At study entry, patients had viral loads less than 50,000 copies/mL, and CD4 cell counts greater than 50 cells/mm3. All patients switched from their previous regimen to a compact two pills twice a day regimen of Ziagen+Combivir.

The study enrolled 87 patients who at entry, had a median viral load of 1,259 and median CD4 cell count of 506. At baseline, 33 percent of patients had less than 400 viral copies and 12 percent had less than 50 copies. After 16 weeks of treatment with Ziagen+Combivir, 72 percent of patients to that time point (28 patients) had less than 400 viral copies and 54 percent had less than 50 copies. Furthermore, median CD4 cell counts among these patients at 16 weeks went up to 536.

Today's study results were presented at the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Diego, CA.

"These preliminary data provide promise that the combination of Combivir+Ziagen may effectively suppress HIV replication in patients previously treated with other nucleoside analogues," said Keith Henry, M.D., director of HIV Programs, Regions Hospital, St. Paul, MN, and lead investigator of the study. "These data also suggest that the combination may allow patients to preserve future treatment options."

Ziagen containing treatment regimens were the subject of more than 20 scientific presentations this past summer at the 12th World AIDS Conference in Geneva, Switzerland. These presentations, while involving various combinations in patients with varying degrees of pre-treatment, showed that regimens containing Ziagen appear to have significant antiviral power while being generally well-tolerated.

In the study reported today, and across all clinical trials of Ziagen to date, the most commonly reported adverse events include nausea, malaise and fatigue, headache, vomiting and diarrhea. In clinical trials involving Ziagen, approximately 3 percent of patients have experienced a hypersensitivity reaction consisting of fever with nausea and/or malaise and possibly an accompanying rash. Symptoms of this reaction generally occur from between several days to six weeks after initiating therapy and resolve following discontinuation of Ziagen. Patients experiencing this reaction must not take Ziagen again as restarting the drug after a hypersensitivity reaction has resulted in cases of a life-threatening, and in one instance fatal, reaction.

The most commonly reported side effects associated with treatment with Combivir or Epivir(R) (lamivudine)+Retrovir(R) (zidovudine) are headache, nausea, malaise and fatigue, runny nose and nasal congestion, diarrhea, low white blood cells and anemia. In addition, Epivir as well as Retrovir and other nucleoside analogues have been associated with rare but potentially life-threatening lactic acidosis and hepatomegaly.

Glaxo Wellcome submitted a New Drug Application (NDA) for Ziagen to the Food and Drug Administration in June 1998. Ziagen is currently available through an expanded access program to patients who are no longer maintaining viral suppression with current treatments.

Ziagen was discovered and is being developed by Glaxo Wellcome. The rights to related compounds and technology, including intermediates used in the manufacture of Ziagen, resulting from research by Dr. Robert Vince, et. al, were licensed to Glaxo Wellcome by the University of Minnesota in 1992.

Glaxo Wellcome is the pharmaceutical industry leader in HIV research and therapies. In addition to developing the investigational drugs Ziagen and Agenerase(TM)(amprenavir; protease inhibitor), the company currently manufactures and markets Epivir, Retrovir and Combivir.

SOURCE: Glaxo Wellcome
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